Current Medications

Medicare site may be updated without notice so please check the link for the latest information - this page is current as at 31 October 2017.

Authority to prescribe ambrisentan (Volibris®), bosentan monohydrate (Tracleer®), epoprostenol sodium (Flolan®), iloprost trometamol (Ventavis®), macitentan (Opsumit®), riociguat (Adempas®) and sildenafil citrate (Revatio®) for eligible patients, through the Pharmaceutical Benefits Scheme (PBS) is provided under Section 100 of the National Health Act 1953.

Interchangeability between ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, macitentan, riociguat and sildenafil citrate (known as the PAH agents) to treat primary pulmonary hypertension (PPH) or pulmonary arterial hypertension (PAH), in eligible patients is defined in the Schedule of Pharmaceutical Benefits (the Schedule).                                                             For more information, click here.

Ambrisentan is available under the PBS (with authority) for treatment of:

• World Health Organization (WHO) functional Class III or IV Idiopathic Pulmonary Arterial Pulmonary Hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH , and
• WHO functional Class III or IV PAH secondary to connective tissue disease

Bosentan monohydrate is available under the PBS (with authority )for the treatment of:

• World Health Organisation (WHO) functional Class III or IV (iPAH) or anorexigen-induced PAH or hereditable PAH WHO Functional Class III or IV PAH secondary to connective tissue disease, and
• WHO functional Class III or IV PAH associated with a congenital systemic-to-pulmonary shunt, including Eisenmenger's physiology.

Epoprostenol sodium is available under the PBS (with authority) for the treatment of:

• WHO functional class III or IV iPAH or anorexigen-induced PAH or hereditable PAH
• WHO functional Class lV PAH secondary to connective tissue disease    
• WHO Functional Class III iPAH or anorexigen-induced PAH or hereditable PAH where the patient has previously failed treatment with a PBS-subsidised PAH agent, and 
• WHO Functional Class III PAH secondary to connective tissue disease where the patient has previously failed treatment with a PBS-subsidised PAH agent

Iloprost trometamol is available under the PBS (with authority) for the treatment

• WHO Functional Class IV iPAH or anorexigen-induced PAH or hereditable PAH
• WHO Functional Class IV PAH secondary to connective tissue disease
• WHO Functional Class III iPAH or anorexigen-induced PAH or hereditable PAH where the patient has previously failed treatment with a PBS-subsidised PAH agent
• WHO Functional Class III PAH secondary to connective tissue disease where the patient has previously failed treatment with a PBS-subsidised PAH agent, and
• WHO Functional Class III or IV drug-induced PAH

Macitentan is available under the PBS as an authority required item for the treatment of:

• WHO III or IV IPAH or anorexigen-induced PAH or heritable PAH
• WHO functional Class III or lV PAH secondary to connective tissue disease and
• WHO functional Class III or IV PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology).

Rioicguat is available under the PBS (with authority) for the treatment of:

•  WHO Functional Class III or IV iPAH or anorexigen-induced PAH or hereditable PAH
•  WHO Functional Class III or IV PAH secondary to connective tissue disease, and
•  WHO III or IV PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology)

Sildenafil citrate is available under the PBS (with authority) for the treatment of:

• WHO functional Class III iPAH or anorexigen-induced PAH or hereditable PAH, and
• WHO functional Class lll PAH secondary to connective tissue disease.
  

Tadalafil is available under the PBS (with authority) for the treatment of:

• WHO functional Class III iPAH or anorexigen-induced PAH or hereditable PAH, and
• WHO functional Class III PAH secondary to connective tissue disease.

Important: These PAH treatments are not PBS subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of that predicted.

Ambrisentan

Ambrisentan (Volibris®/Letairis®) should be taken orally at a dose of 5mg once daily. Additional benefit may be obtained by increasing the dose to 10mg. It is available in a pack size of 30m tablets. 

Caution: ambrisentan is a category X medicine and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least 3 months following cessation of treatment with this medicine.

Children

There is no data available on the use of ambrisentan in patients under 18 years of age, and therefore its use in this age group is not recommended.

Bosentan monohydrate

Bosentan monohydrate (Tracleer®) is available in 62.5 mg and 125 mg tablets. No applications for increased maximum quantities will be authorised.

Caution: Bosentan monohydrate is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least three months following cessation of treatment with this drug.

The quantity approved will be based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved product information. click here to download a medications table.

Dose adjustment for patients with low body weight

In patients with a body weight below 40 kg but who are over 12 years of age the recommended initial and maintenance dose is 62.5 mg twice daily.

Dose adjustment in children

There is limited experience with the use of bosentan in children. On the basis of the available information, the recommended doses in children aged three years and over are listed in the table above.

Epoprostenol sodium

Epoprostenol sodium (Flolan®) is available in the following pack sizes:

• one vial containing equivalent to epoprostenol sodium 500 microgram, supplied with one 50 mL vial of buffer solution
  
• one vial containing equivalent to epoprostenol sodium 1.5 mg, supplied with two 50 mL vials of buffer solution.
  

The quantity approved will be based on the dosage recommendations in the TGA approved product information.

Iloprost trometamol

Iloprost trometamol (Ventavis®) is available as a nebuliser solution, 27.2 microgram (equiv. iloprost 20 microgram)/2 mL.

The quantity approved will be based on the dosage recommendations in the TGA approved product information.

Each inhalation session should start with 2.5 micrograms iloprost (as delivered at the mouthpiece of the inhalation device). The dose can be increased to 5.0 micrograms iloprost according to the individual need and tolerability.

The dose per inhalation session should be administered six to nine times per day according to the individual need and tolerability.

Depending on the desired dose at the mouthpiece and on the nebuliser, the duration of an inhalation session is approximately five to 10 minutes.

Macitentan

Macitentan (Opsumit®) is available in 10mg tablets. Pack size 30 tablets. No applications for increased maximum quantities will be authorised. The quantity approved will be based on the dosage recommendations in the TGA approved product information.

Rioicguat

Riociguat (Adempas )                                                                                                                                                                                                Details to come

Sildenafil citrate

Sildenafil citrate (Revatio®) is available in 20 mg tablets. No applications for increased maximum quantities will be authorised. The quantity approved will be based on the dosage recommendations in the TGA approved product information.

Tadalafil

Tadalafil (Cialis®/Adcirca® is available in 20 mg tablets. No applications for increased maximum quantities will be authorised.

The quantity approved will be based on the dosage recommendations in the TGA approved product information.